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Revisiting the Familiar: Time to Re-evaluate the GVD?

By
Xcenda
|
May 15, 2017

While nearly all international market access stakeholders are familiar with the global value dossier (GVD), with ever-increasing demands by health technology assessment (HTA) agencies, it is becoming more difficult to create an impactful, descriptive, and useful document that supports local product submissions. We review the current state of the GVD, the challenges associated with developing an effective GVD, and key actions that can be undertaken to optimize the utility of the GVD.

HTA QUARTERLY | SPRING 2017

Revisiting the Familiar: Time to Re-evaluate the GVD?

By Ryan Clark, PharmD, MBA, MS and Evelyn Sarnes, PharmD, MPH

The global value dossier (GVD) is considered a core component of the global market access strategic and tactical planning for new technologies and is often a central deliverable from global health economics and outcomes research (GHEOR) for local operating companies. While nearly all international market access stakeholders are familiar with the GVD, with ever-increasing demands by health technology assessment (HTA) agencies, it is becoming more difficult to create an impactful, descriptive, and useful document that supports local product submissions. This article will review the current state of the GVD, the challenges associated with developing an effective GVD, and key actions that can be undertaken to optimize the utility of the GVD.

Same Document, New Environment: a Look at the Current GVD

The GVD has been used by manufacturers as an internal repository of crucial information supporting local submissions for over a decade. While the general structure and information contained in the document has largely remained the same, the primary objective of the GVD has changed over time, resulting in wide variation among manufacturers. These may include:

It is unsurprising that there is not alignment on the primary objective of the GVD, considering there is no standardized GVD template or guidance, unlike the US-based AMCP dossier or the UK-based National Institute for Health and Care Excellence (NICE) single technology appraisal (STA). Underlying all of these objectives, however, is a goal for the GVD to be a useful market access tool at the local level. Because of the specific requirements of different HTA agencies, including the requirement in some countries (eg, Germany and France) that the submission is in the native language, and the need for local market data, it would be very difficult and resource intensive to develop a GVD that can be directly inserted into local submissions. While organizations like EUnetHTA are advocating to streamline the multi-agency submission process,1 the reach and acceptance of such coordinated efforts remain low. As a result, it is important that the GVD focuses on aspects that are most vital in supporting the local HTA submission.

In a study conducted by Xcenda with 42 manufacturer affiliates, most respondents found the following data elements extremely or very important for an HTA submission2:

*23 of 42 respondents received a GVD prior to their HTA submission.

The most common characteristic of the GVD that survey respondents found to impact its utility at the local level is that, while comprehensive, the content of the GVD isn’t relevant to their specific country (or HTA agency). For example, the relative value of quality of life or the acceptance of surrogate outcome measures can be very different by region; so it is critical that local experts provide feedback on the most important outcome measures in their country. Manufacturers may encounter problems if the GVD is developed without input from those who will ultimately be using the GVD for their HTA submission and/or if the GVD does not align closely with local HTA frameworks. Local input is especially important for those sections where HTA agencies often require country-specific data, like epidemiology, treatment patterns, economic burden, and cost-effectiveness/budget impact. When these local data are absent in the GVD, it forces affiliates to conduct their own literature reviews to identify and develop these sections for their local submission. Tailoring the content for HTA is also critical for sections such as economic modeling and the summary of clinical data. Because of intricacies and nuances of local HTA requirements, it is critical that local teams familiar with those processes be intimately involved in the creation of this section and the supporting materials. For example, when considering a product’s budget impact/cost-effectiveness, it would be important that representatives from France (along with other markets of interest) weigh in on the development of the economic model and ensure the major requirements of a Haute Autorité de santé (HAS) submission are met (in the case of France, by emphasizing the budget impact of the technology vs the quality-adjusted life year [QALY]-based cost-effectiveness that is required by NICE in the UK).

Another commonly cited issue with the GVD is that it may not clearly communicate a core value proposition or it is not transparent in how the value proposition is supported. When designed well, the GVD can very effectively deliver a robust starting point that provides a cohesive value story for local affiliates to use alongside other tools and resources. Unfortunately, it is not always clear in the GVD what level of evidence is present to support value statements made in the dossier. It is important to note this does not suggest affiliates want more data inserted into the GVD simply for the sake of having more data; rather, they are interested in a comprehensive value story with the complete suite of evidence available in support.

Strategic Actions to Maximize GVD Impact and Usefulness

So how can the GVD be made more useful for local affiliates and provide a more unified message to the numerous HTA agencies represented? Involving local affiliates (or those familiar with a given market’s HTA processes/requirements and/or who will be drafting the HTA submission) is critical to the GVD being more widely utilized. It is important to develop a feedback process in which affiliates can at least provide relevant input and data from their local market to proactively address the issue of relevancy. Another aspect to consider in creating a successful GVD is taking into account the language of the end user. Inadvertently, headquarters may take for granted the common use of the English language; local affiliates who must take the GVD and adapt for their own local HTA submissions may find the translation to be a very significant barrier to the timely use of the GVD . Local discussion on the language used in the GVD is important to understand which markets may require or request translation.

With several local affiliates all providing input on the GVD, the process and timelines can get complex, which may result in missing the critical window when the GVD is needed for local HTA submissions. In the survey described above, 36% of local affiliates who were involved in an HTA submission did not have a GVD prior to finalizing the submission dossier—though it is unknown if this was intentional or not. When asked about GVD timing, most affiliates preferred to have the GVD approximately 1 year prior to regulatory approval, which implies the GVD development process must begin well before the preparation for an HTA submission.

While they can be significant, these challenges are not insurmountable. The decision to develop a GVD should be elevated from a “checklist” item for global market access to careful consideration by the various stakeholders involved in order to fully recognize the potential such a global value document can provide to an organization. It is imperative to have in-house expertise or a strategic partner that not only understands how the document is used by local affiliates for HTA submissions but also can appropriately leverage the product’s clinical and economic value proposition . The GVD is a very valuable tool and certainly will remain as a core component of an organization’s global market access strategy; through innovative solutions, the GVD can thrive and be more willingly and efficiently used by local affiliates.